Safety Management Systems &
Reliability
Chris W. Hayes, MD
CPSOC
April 12, 2011
Overview
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How safe is healthcare?
What is Safety Management System
System defences
“Swiss Cheese” model
Reliability
– Group exercise
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Summary
How Safe is Healthcare?
How Safe is Healthcare?
 Canadian Adverse Events Study
– 7.5% of admission suffer an AE
– 9250 to 23750 preventable deaths/yr
– Death from AE in 1/165 admissions
Baker R. The Canadian Adverse Events Study. CMAJ 2001.
How Safe is Healthcare?
Health
Care
Why Is This So?
“Medicine used to be simple, ineffective and
relatively safe.
Now it is complex, effective and potentially
dangerous.”
Sir Cyril Chantler
Chairman, King’s Fund
Why Is This So?
 Clinical medicine has become extremely
complex:
– Increased patient volume, acuity
– Growing therapeutic options
– Expanding knowledge, evidence
– Surprises, uncertainty
– Many sources of (incomplete) information
– Interruptions and multitasking
Why Is This So?
AND…
 Safe and quality outcomes (for the most part)
dependent on healthcare providers [humans]
 Is that a problem?
Why Is This So?
Strengths
Large memory capacity
Large repertory of responses
Flexibility in applying
responses to information
Ability to react creatively to
the unexpected
•Compassionate / caring
Limitations
Difficulty in multitasking
Difficulty
in recalling
Gets worse
with: detailed
information
-fatigue quickly
Poor
computational ability
-stress
-lack of
knowledge
Limited
short
term memory
-lack of confidence
Perception
-lack of supportive work
environment
Where Should We Be?
Health
Care
Blood Transfusion
Anesthesia
How Do We Get There?
 Healthcare needs to become more like an ultrasafe industry
– Learn from other ultra-safe industries
– Learn from components of medicine that have
achieved high degree of safety
– Develop a strong Culture of Safety
Safety Management
Systems?
 Safety Management System, SMS
– Taken from ultra-safe, HROs
– An organizational approach to safety
– Focuses on the system not the person
A systematic, explicit and comprehensive
process for managing safety risks
Safety Management
Systems?
 SMS origins from aviation industry
– In response to major airline disasters in the 1960’s
– Initial focus on “safety system”
• Made department / individuals responsible for safety
Safety Management
Systems?
Safety Management
Systems?
 SMS origins from aviation industry
– In response to major airline disasters in the 1960’s
– Initial focus on “safety system”
• Made department / individuals responsible for safety
– Realization that to achieve full scale safety goals
need whole organization approach
Safety Management
Systems?
 Main objectives:
– Detecting and understanding the hazards and risks
in your environment
– Proactively making changes to minimize risks
– Learning from errors that occur in order to prevent
their reoccurrence
Safety Management
Systems?
 With the understanding that:
– Safety is everyone’s job
Culture
Of
– Embedded at all levels
Safety
– Humans are fallible
– System defences need to be designed / redesigned
to protect patients
System Defences
 Redundancy and Diversity
– Need for multiple layers
– Need for multiple approaches
 2 Types of defences
– Hard defences – engineered features, forcing functions,
constraints
– Soft defences – rules, policies, double-checks, signoffs,
auditing, reminders
System Defences
 Hazardous domains (nuclear power)
– activities are stable and predictable
– heavy reliance on engineered safety features.
 Healthcare defences
– most of the defences are human skills.
– sharpenders (nurses, junior MDs) are the ‘glue’
that holds these defences together.
System Defences
 Disaster happens when:
– There are initiating disturbances, AND
– The defences fail to detect and/or protect
– often necessary for several defences to fail at the
same time.
 Incidence of error (losses) depends on:
– The frequency of initiating disturbance (hazards)
– The reliability of the system defences
Reason’s “Swiss Cheese”
Model
Defences are only as strong as their weakest link!
Some holes due
to active failures
Losses
Hazards
Other holes due to
latent conditions
A System Model of Accident Causation
Reason’s “Swiss Cheese”
Model
Defences are only as strong as their weakest link!
Some holes due
to active failures
Losses
Hazards
Other holes due to
latent conditions
A System Model of Accident Causation
An Example
 SMH ICU
– Patient with CVA has seizure in ICU
– MD orders 1g Dilantin over 20 minutes
– MD called to reassess patient for severe
hypertension and ST changes
– Metoprolol given with bradycardia but little BP
effect
– Pt suffers large MI and CHF
An Example
Reason’s “Swiss Cheese”
Model
Medication
organization
Manufacturer
Hazards
Sound-alike
look-alike
drug
Purchasing
Losses
CHF/MI
RN/MD Double-check
Making Your System Safer
 Accept that errors will be made
 Incorporate features of Ultra-safe SMS
– Actively seek hazards (FMEA, Walk-Rounds) and
learn from errors that have occurred (RCA)
– Create multiple defense layers to prevent error
(hard and soft as appropriate)
– Make safety everyone’s job
Making Your System Safer
“We cannot change the human condition
But…
we can change the conditions under which
humans work”
James Reason
Making Healthcare Reliable
 How do you close the hole’s in the Swiss
Cheese
– Design strong defences
• Engineer problem away
– Include human factors design (later)
– Build in reliable processes
Reliability
Reliability
 Measured as the inverse of the system’s failure rate
 Failure free operation over time
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Chaotic: failure in greater than 20% of events
10-1: 1 or 2 failures out of 10
10-2: <5 failures per 100
10-3 : <5 failures per 1000
10-4 : <5 failures per 10000
Reliability
 Reliability principles, used to design systems
that compensate for the limits of human
ability, can improve safety and the rate at
which a system consist-ently produces desired
outcomes.
Reliability
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Three-step model for applying principles of
reliability to health care systems:
1. Prevent failure
2. Identify and Mitigate failure
3. Redesign the process based on the critical failures
identified.
Table Exercises – The case
 As your organization’s PSO your are made aware of
several patients who received cardiopulmonary
resuscitation following Code Blue calls despite
known advance directives stating the patients’ wishes
were to be DNR
 In both cases the DNR order was in the chart but
were not easily located nor were the assigned nurses
aware of the order
 You were aware that No Resuscitation Policy that
contained a standardized order form was created,
approved by senior management and MAC and was
available for use
POLICY
PRACTICE
Group Exercise
 Identify a process to make more reliable
 Describe the current process (flow chart)
 Identify where the defects occur in the current
system
 Set a reliability goal for the segment
Roll Out - The Usual Way
B
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Initial
Plan
IDEA
Discus
s
&
Revise
Discus
s
&
Revise
Discus
s
&
Revise
Roll Out - The Better Way
B
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Plan
IDEA
Applying Reliability
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Understand the process
Find the defects, bottlenecks and workarounds
Plan process improvements
Test them…small scale, front-line
involvement….until they work
 Look for failures and …redesign
Summary
 Healthcare has high error rate
 Understanding hazards and learning from errors
vital
 Defences that rely on more than human vigilance
need to be in place
 Need a strong culture of safety
 Need to build reliable processes
 Start small….involve frontline
 Safety improvement is everyone’s job
Thank You!
 Questions?
 chayes@cpsi-icsp.ca